Russia: changes in the medical device regulations

In October 2016 the Russian Ministry of Health published the multiple amendments to Russian medical Device regulation.  The several draft documents are intended to implement significant changes into current key medical device regulations.  In general, the trend of proposed changes is in line with Eurasian medical device harmonization.
Published documents are currently undergoing public and expert evaluation and they are expected to come into force by the end of the year.

For more information please click here (link in Russian).